spinal and bulbar muscular atrophy (SBMA) MedDRA version: 15.0 Level: HLGT Classification code 10029317 Term: Neuromuscular disorders System Organ Class: 10029205 - Nervous system disorders MedDRA version: 15.0 Level: SOC Classification code 10029205 Term: Nervous system disorders System Organ Class: 10029205 - Nervous system disorders MedDRA version: 15.0 Level: LLT Classification code 10047868 Term: Weakness of limbs System Organ Class: 10028395 - Musculoskeletal and connective tissue disor
Conditions
Interventions
Trade Name: MONORES*30CPR 20MCG
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Clenbuterol
Concentration unit: µg microgram(s)
Concentration number: 20-
Sponsors
AZIENDA OSPEDALIERA DI PADOVA
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Genetically confirmed SBMA male patients with more than one of the following symptoms: muscle weakness, muscle atrophy, bulbar palsy or hand tremor. 2) Patients able to walk independently along a flat corridor with or without the of a cane or similar equipment. 3) Patients who were 30 to 70 years old at the time of informed consent 4) Patients who gave written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) documented cardiac disease. 2) documented hypersensibility to beta2 agonists.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the study is to investigate the safety and tolerability of clenbuterol of the SBMA;Secondary Objective: NA;Primary end point(s): change from the baseline of the walk distance (mt) in six minutes (6-min walk test) at 12 months. | — |
Countries
Italy
Outcome results
None listed